PERmixon® in LUTS Evaluation Study (PERLES)

Phase 4

Completed

• Conditions: Benign Prostatic Hyperplasia (BPH)
• Interventions: Drug: Tamsulosine LP; Drug: Permixon® 160 mg; Drug: Placebo matching Tamsulosine LP; Drug: Placebo matching Permixon® 160 mg

• Registration Number: NCT02121613
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

The aim of this study is to support the efficacy of Permixon 160 mg b.i.d. in treating subjects with symptomatic Benign Prostatic Hyperplasia (BPH), compared to placebo, using Tamsulosine LP 0.4 mg as a reference treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-18
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-23
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 833

Inclusion Criteria

• Male subject
• Between 45 and 85 years old
• Subject with bothersome lower urinary tract symptoms (LUTS) due to BPH such as frequency (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream
• Subject naive to any prior treatment for LUTS due to BPH
• Prostate enlargement at digital rectal examination (DRE) suggestive of BPH
• I-PSS > 12 at enrolment visit and at inclusion visit
• QoL I-PSS score ≥ 3 evaluated at enrolment visit and at inclusion visit

Exclusion Criteria

• Urological history such as urethral stricture disease and/or bladder neck disease, active (at enrolment and/or inclusion or recurrent urinary tract infection, stone in bladder or urethra)
• Any neurologic or psychiatric disease/disorder interfering with detrusor or sphincter muscle
• Insulin-dependent diabetes mellitus and non-controlled non insulin-dependent diabetes mellitus
• Known severe renal insufficiency or creatinine clearance < 30 ml/mn
• Known liver insufficiency or clinically significant abnormal liver function tests
• History of, or concomitant, cardiac arrhythmia or angina pectoris
• Orthostatic hypotension at enrolment or inclusion visit
• Known hypersensitivity to one of the constituents of the study drugs
• Is participating in another clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamsulosine LP & Placebo	Tamsulosine LP	Active control arm
Placebo	Placebo matching Tamsulosine LP	-
Tamsulosine LP & Placebo	Placebo matching Tamsulosine LP	Active control arm
Permixon® 160 mg & Placebo	Permixon® 160 mg	-
Permixon® 160 mg & Placebo	Placebo matching Permixon® 160 mg	-
Placebo	Placebo matching Permixon® 160 mg	-
Permixon® 160 mg & Placebo	Placebo matching Tamsulosine LP	-
Tamsulosine LP & Placebo	Placebo matching Permixon® 160 mg	Active control arm

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (I-PSS score) change	Day 180	I-PSS score change from baseline to D180